The human spine 29 comprises individual vertebrae 30 that interlock with each other to form a spinal column, shown in FIG. 1A. Referring to FIGS. 1B, 1C, 2A, 2B, 3 and 4, each vertebra 30 has a cylindrical bony body (vertebral body) 32, two pedicles 48a, 48b extending from the vertebral body 32, a lamina 47 extending from the pedicles 48a, 48b, three winglike projections (two transverse processes 33, 35 extending from the pedicles 48a, 48b, respectively, and one spinous process 34 extending from the lamina 47), pars interarticularis 36a, 36b, two superior facets 46a, 46b extending from the pedicles 48a, 48b, respectively, and two inferior facets 45a, 45b extending from the lamina 47. The pars interarticularis 36a, 36b connect the superior 46a, 46b and inferior 45a, 45b facets of the vertebra, respectively, on either side of the spinous process 34. The bodies of the vertebrae 32 are stacked one on top of the other and form the strong but flexible spinal column. The spinous process 34, lamina 47, pars interarticularis 36a, 36b, superior facets 46a, 46b, inferior facets 45a, 45b, transverse processes 33, 35, and pedicles 48a, 48b are positioned so that the space they enclose forms a tube, i.e., the spinal canal 37. The spinal canal 37 houses and protects the spinal cord and other neural elements. A fluid filled protective membrane, the dura 38, covers the contents of the spinal canal. The spinal column is flexible enough to allow the body to twist and bend, but sturdy enough to support and protect the spinal cord and the other neural elements. The inferior facets 45a, 45b of one vertebra fit perfectly into the superior facets 46a, 46b of the vertebra below it, thereby forming left and right facet joints 50a, 50b. The facet joints 50a, 50b provide stability and guide motion in the spine. Like the bones that form other joints in the human body, such as the hip, knee, or elbow, the articular surfaces of the facet joints are covered by a layer of smooth cartilage, surrounded by a strong capsule of ligaments, and lubricated by synovial fluid.
The vertebrae 30 are separated and cushioned by thin pads of tough, resilient fiber known as inter-vertebral discs 40. Inter-vertebral discs 40 provide flexibility to the spine and act as shock absorbers during activity. There is a small opening (foramen) 42 between each vertebra 30, through which nerves 44 pass and go to different body parts. When the vertebrae are properly aligned the nerves 44 pass through without a problem. However, when the vertebrae are misaligned or a constriction 15 is formed in the spinal canal, the nerves get compressed 44a and may cause back pain, leg pain or other neurological disorders. Disorders of the spine that may cause misalignment of the vertebrae or constriction of the spinal canal include spinal injuries, infections, tumor formation, herniation of the inter-vertebral discs (i.e., slippage or protrusion), arthritic disorders, and scoliosis. In these pathologic circumstances, surgery may be tried to either decompress the neural elements and/or fuse adjacent vertebral segments. Decompression may involve laminectomy, discectomy, or corpectomy. Laminectomy involves the removal of part of the lamina 47, i.e., the bony roof of the spinal canal. Discectomy involves removal of the inter-vertebral discs 40. Corpectomy involves removal of the vertebral body 32 as well as the adjacent disc spaces 40. Laminectomy and corpectomy result in central exposure of the dura 38 and its contents. An exposed dura 38 puts the neural elements and spinal cord at risk from direct mechanical injury or scarring from overlying soft tissues. Scarring is considered a major cause for failed back syndrome in which patients continue to have back and leg pain after spinal surgery. Current methods to decrease the risk of developing this syndrome include covering the dura with fat harvested from the patient's subcutaneous tissues or using a synthetic material. However, no material as yet has been used that completely or significantly prevents scarring of the dura and nerve roots after spine surgery in humans.
Furthermore, laminectomy predisposes the patient to instability through the facet joints and may lead to post-laminectomy kyphosis (abnormal forward curvature of the spine), pain, and neurological dysfunction. Therefore the surgeon needs to stabilize the spine after laminectomy procedures and after corpectomy. One spine stabilization method is fusion. Fusion involves the fixation of two or more vertebrae. Fusion works well because it stops pain due to movement of the intervertebral discs 40 or facets 45a, 45b, 46a, 46b, immobilizes the spine, and prevents instability and or deformity of the spine after laminectomy or corpectomy. However, spinal fusion limits spinal mobility. Maintaining spinal mobility may be preferred over fusion in some cases to allow more flexibility of the spine and to decrease the risk of junction problems above and below the level of the fixation due to increased stress.
An arthritic facet joint may also cause back pain (facet arthropathy). Since the majority of the motion along the spine occurs at the facet joints, fusing the diseased facet would often relieve pain but again at a high cost of fusing across at least one spinal segment thus preventing motion and effectively increasing stresses at the adjacent facet joints. Increased stresses predispose facet joints to accelerated arthritis, pain, and instability requiring additional surgery to fuse these levels. This cyclic process results in an overall decreased mobility of the spine. Therefore, it is an attractive alternative to attempt to replace the diseased facet without resorting to fusion, thus avoiding significant limitation in mobility of the spine. The obvious solution would be to replace the opposing surfaces of each facet to preserve motion between the surfaces. However, any efforts to replace the facets at their natural location necessitate destroying the facet capsule and risks producing an unstable joint. Therefore, it is desirable to achieve spine stabilization that preserves mobility, and does not cause tissue scarring or destroy the facet capsule. It is also desirable to be able to implant the stabilization device percutaneously utilizing minimally invasive surgery.